MX2007016062A

MX2007016062A - Packing for infusion set and method of applying an infusion set.

Info

Publication number: MX2007016062A
Application number: MX2007016062A
Authority: MX
Inventors: Lasse Wesseltoft Mogensen; Jesper Toft Olsen; Carl Johan Daniel Ahman; May Britt Svendstrup; Steffen Gyrn
Original assignee: Unomedical As
Priority date: 2005-06-28
Filing date: 2006-06-08
Publication date: 2008-03-10
Also published as: RU2408391C2; US7621395B2; DK1896097T3; CN101267853B; KR20080031693A; CN101267853A; CA2612664A1; AU2006264122B2; US20100179508A1; DE602006016123D1; AU2006264122A1; RU2007149533A; NO20080459L; ATE477010T1; ES2352409T3; EP1896097B1; US20070021729A1; WO2007000162A2; EP1896097A2; WO2007000162A3

Abstract

The present invention relates to a packing for an infusion set. An infusion set for intermittent or continuous administration of a therapeutical substance, such as insulin, comprises an infusion part having a cannula penetrating the skin of a patient and a connector which connects the infusion part with a medical device such as an adaptor for a syringe or an insulin pump. The insertion of the infusion part will be performed with an insertion needle which is delivered together with the infusion part under sterile conditions. The packaging comprises an impenetrable part (7) protecting the surroundings from the insertion needle and a removal part (8) which is to be removed by the user before applying the infusion part. The inner surface of the impenetrable part (7) is provided with means (7a) for releasable retaining at least a part of the infusion set.

Description

PACKAGING FOR INFUSION GAME AND PAR METHOD APPLYING AN INFUSION GAME Technical Field The present invention relates to a packaging for an infusion set. An infusion set for intermittent or continuous administration of a therapeutic substance, such as insulin, comprises an infusion portion having a cannula penetrating the skin of a patient and a connector connecting the infusion portion with a medical device such as a medical device. adapter for a syringe or an insulin pump. The insertion of the infusion part will be done with an insertion needle that is supplied together with the infusion part under sterile conditions. BACKGROUND OF THE INVENTION US 5,968,011-A is related to a subcutaneous low-profile infusion set for administering a medication or a therapeutic fluid to a patient. It would be possible to apply this infusion set according to the present invention. US 6,355,021-B1 relates to a medical puncture device. This device comprises a rigid needle mounted on a needle hub (2), and the needle hub comprises a handle part (3) and a shell part (4). This device could be used to insert an infusion set as described in US 5,968,011-A. US 2003/00130619 A1 relates to an insertion device and an insertion set. Figures 35 to 40 and the corresponding text (

[0099] -

[0107]) describe an insertion device that could be applied in connection with the present invention. Description of the Invention One objective of the invention is to make the insertion of an infusion device easier, more flexible and convenient for the patient. According to the present invention it is possible to combine a standard infusion device with for example an inserter for automatic insertion or a handle for manual insertion as the inventive packing ensures the stability that is necessary in order to maintain the infusion set and the needle hub in position while a secondary device in the shape of a grip or inserter, chosen by the patient, is pushed against and connected to it. When the packaging is used as a kind of gripper during the insertion procedure, contamination of the infusion device is also kept to a minimum. It is not essential if the secondary device connects releasably or non-releasably to the infusion device while it is connected to it since both possibilities have their advantages but the secondary device must form a stronger connection with the infusion set than the infusion set form with the packaging according to the invention so that the user removes the package infusion set by simply pulling the secondary packaging device. The invention relates to a packaging for an infusion set comprising an infusion part and a needle hub, wherein the needle hub is combined with an insertion needle. The packing comprises an impenetrable part that protects the surroundings of the insertion needle and a removable part that is to be removed by the user before applying the infusion set wherein the inner surface of the impenetrable part is provided with releasable retaining means at least part of the infusion set. Preferably the proximal side of the infusion set is provided with an adhesive, and the adhesive can be covered with a release layer. In one embodiment of the invention the release layer covering the adhesive is partially fastened to the impenetrable part or is attached to a part that is connected to the impenetrable part, an appropriate release layer for an adhesive sheet material of the document is known. WO 2004/087240. This will cause the release layer to be removed when the infusion set and the needle hub are removed from the packing. According to this embodiment, the release layer can be in the form of a band where one end of the band is secured to the impenetrable part or is attached to a part that integrates with the impenetrable part. In one embodiment of the invention the impenetrable part is made of a hard material. Preferably the impenetrable part is made of polypropylene (PP), polyethylene (PE HD) or PVC. In one embodiment of the invention the needle hub is on its distal side provided with means for retaining a device. Preferably the needle hub is provided with means for retaining an inserter. More preferred, the needle hub can pick up and hold an inserter when the inserter is pushed towards the needle hub on the distal side. An inserter is not shown in the figures but a suitable inserter is described in the US patent application no. 2003/0130619 figs. 35-38. In a preferred embodiment the infusion set is retained releasably by the retention means formed as an integrated part of the impenetrable part of the packing.

In this embodiment the infusion part can be promoted with corresponding means that are releasably connected to the retention means. According to this embodiment, the retaining means can be formed as vertical walls of the impenetrable part at an angle between -45 ° and 45 ° where 0 ° is orthogonal to the near surface of the impenetrable part and the corresponding medium can be formed. form with a cylinder or truncated cone intrigued with the infusion part. In a much more preferred embodiment the corresponding means comprises a truncated cylinder or cone formed by a slit or recess in the infusion portion making it possible for the proximal end of the corresponding medium to be aligned to the proximal surface of the infusion portion. In another embodiment the retaining means is formed of a relatively soft material which material can be penetrated by the insertion needle and the soft material connects non-releasably to the impenetrable part of the packing. In a preferred embodiment a support part parallel to the proximal surface of the infusion set is attached to the impenetrable part or formed as an integrated part of the impenetrable part. In another preferred embodiment the retaining means comprises an opening for the guide and a support portion parallel to the proximal surface of the infusion set. In this embodiment, the corresponding medium may correspond to a cylinder or a truncated cone projecting from the proximal surface of the infusion part. The invention also relates to a method for applying an infusion set comprising an infusion part and a needle hub where the needle hub is combined with an insertion needle, which method comprises the following steps: removing the part removable from packing, attach a device to the needle hub, remove the infusion set from the impenetrable part of the packing when pulling the device, and remove the release layer covering the adhesive if a release layer is present, place the proximal end of the infusion set that aims against the user's skin, penetrate the user's skin by means of the insertion needle in this way placing the infusion part and securing the infusion set to the patient's skin, removing the device and the needle hub leaving the infusion set in position. In a preferred embodiment the method comprises the following steps: removing the removable part of the packing, attaching an inserter to the needle hub, - removing the infusion set from the impenetrable part of the packing by pulling the inserter, and removing the release layer that cover the adhesive if a release layer is present, - place the proximal end of the infusion set that points against the user's skin, activate the inserter that causes the insertion needle to penetrate the skin and place the infusion part, ensuring the infusion set to the patient's skin, remove the inserter and the needle hub leaving the infusion set in position. The invention also relates to a method for applying an infusion set comprising an infusion part and a needle hub where the needle hub is combined with an insertion needle, which method comprises the following steps: - removing the part removed from the packing, attach a device to the needle hub, remove the infusion point from the impenetrable part of the packing and remove the release layer covering the adhesive when pulling the device, place the proximal end of the infusion set that points against the skin of the user, - penetrate the user's skin by means of the insertion needle in this way placing the infusion part, and securing the infusion set to the patient's skin, removing the device and the needle hub leaving the infusion set in position. It is possible to press or load the inserter / secondary device both before and after the infusion set has been removed from the impenetrable part of the packaging when the device is pulled. DESCRIPTION OF THE DRAWINGS The invention is explained in more detail below with reference to the accompanying drawings which show preferred embodiments of the inventions. Fig. Shows a known needle hub. Fig. Lb shows the same known needle hub from a different angle. The Fag. 2 shows a known needle hub integrated with an infusion part. Fig. 3 shows an embodiment of the invention where a known needle hub integrated with an infusion part is placed in a protective packing. Fig. 4 shows a second embodiment of the invention where a known needle hub integrated with an infusion part is placed in a protective packing. Fig. 5 shows the third embodiment of the invention where a known needle hub integrated with an infusion part is placed in a protective packaging. Fig. 6 shows a fourth embodiment of the invention where a known needle hub integrated with an infusion part is placed in a protective packaging. Fig. 7 shows an embodiment of the invention where a known needle hub integrated with an infusion part is placed in a protective packing provided with a feature for the removal of a release paper. Figs. 8a-8f show in stages how one embodiment of the invention is to be used. Fig. 9 shows a packaging mode together with an inserter just before the union of the inserter. Fig. 10 shows a packaging mode together with an inserter just after the inserter has been attached to the needle hub. Fig. 11 shows a packaging mode provided with a preferred opening mechanism. FIG. 12 shows a protective packing embodiment without the needle hub observed from above where the packing is provided with legs and a protuberance substantially centered to receive a circular central portion. Fig. 13 shows a first side view of the packaging mode shown in Fig. 12. Fig. 14 shows a second side view of the packaging mode shown in Fig. 12. Fig. 15 shows a packaging mode together with an infusion device. Fig. 16 shows a cross-sectional view B-B of the embodiment shown in Fig. 15. The F g. 17 shows a mode of protective packing wherein the retaining means comprises a separate circular central part.

Fig. 18 shows a sectional view of the retaining means of Fig. 17. Fig. 19 shows a side view of the detection means of Fig. 17. Fig. 20 shows a mode where a known needle hub integrated with a Infusion part is removed from a protective packing with a feature to remove a release paper of two spirals. Figs. 21a and 21b show two embodiments of the invention where the release paper covering the adhesive layer is formed as a surface covering the adhesive layer having two extending parts and a central opening. Definition of the words "Distant side" refers to the side of the device that moves away from the patient. "Near side" refers to the side of the device that faces away from the patient, and will generally be used to describe the part of the device that has a surface that the patient is currently touching. "In tegrado" refers for example in the phrase "attached to a part that integrates with the impenetrable part" to which the part that is integrated is connected non-releasable to the impenetrable part or for example formed of the same piece of material as the impenetrable part for example by molding. "A hard material" as for example mentioned in claim 6, can withstand a certain pressure without being deformed, at least the impenetrable part is made of a hard material must be able to withstand forces experienced within the normal handling of the device. "Relatively soft material" means that this is possible for the insertion needle (3) to penetrate the material in contrast to the hard material. Description of embodiments Fig. 1 shows a modality of a needle hub 1 with a rigid insertion needle 3 and means 14 for retaining a device that could be either a handle or an inserter. The means 14 in this embodiment comprises a cylindrical opening which the opening can receive a corresponding shape mounted on a handle or an inserter when the handle / inserter is pushed towards the needle hub 1. This embodiment of a needle hub is known from the US 6,355,021 -Bl. Fig. Lb shows the same needle hub as fig. the as seen from the side. Fig. 2 shows a mode of the same needle hub 1 as in fig. and lb combined with an infusion portion 2. The infusion portion can be in a part comprising a soft cannula extending from the proximal side of the infusion portion and a connection in the shape of a hub 4 extending from the distal side of the infusion set. In the embodiment of fig. 2 The connection is extending parallel to the patient's skin. The infusion part can also be a combination of two pieces, a part containing the cannula and a connector part, where a cannula is extending from the proximal side of the infusion part while the connection is extending from a distal side of the infusion part. the connecting part. The infusion part 2 is formed with a center piece 5 on the proximal side. The central piece 5 may be extending relatively to the proximal surface of the infusion part 2 or the proximal side of the adhesive 6, as shown in fig. 2, but can also be relatively retracted to these surfaces. If the center piece 5 is retracted it can be formed by a circular recess or slot in the infusion part 2 surrounding the center piece 5. An adhesive layer 6 preferably covered with a release layer 6a is non-releasably attached to the proximal side of the center piece. the infusion part 2. In the embodiment of fig. 2 the cannula is attached to the insertion needle although the cannula is not currently shown in the figure. Fig. 3 shows a combination comprising a bucket of water 1 and an infusion part 2 in an inventive packing mode 7, 8. The packing comprises an impenetrable part 7 preferably formed of a relatively hard plastic such as PP, PE HD or PVC. At least the impenetrable part 7 must be able to withstand forces experienced with the normal handling of the device without being deformed 7 / or penetrated by the insertion needle 3. The impenetrable part 7 covers the proximal side of the combination 1, 2 and to the chosen material and also due to the positioning of the needle 3, as the needle 3 of the needle hub 1 is placed at a certain distance from the packaging surface, the impenetrable part 7 protects the surroundings of the needle. At least a portion of the distal side of the combination 1, 2 is covered by a removable part 8 that is at least partially removed by the user before the device is applied. When placed in the packaging the combination 1, 2 is in contact with a support part 9 which part is attached to or is a part of the inner surface of the packaging. The support part 9 could be circular or in the form of one or more beams, and / or could be fastened to either a central part that reaches towards the periphery without actually touching the periphery or could be fastened to the periphery that is reached In the center. The support part 9 can also function as a release layer like the adhesive 6 meaning that the support part 9 protects the adhesive surface totally or partially during storage. If the support part 9 functions as a release layer it is important to consider the force needed to overcome the release of the infusion part 2 of the support part 9 since the infusion part 2 to some degree is subject to the part of the infusion part 2. support 9 by adding. In order to regulate the traction between the infusion part 2 and the support surface 9 and by which also regulate the force necessary to overcome the release of the infusion part 2, a suitable fraction of the adhesive surface 6 can be covered by a release layer that has no traction on the support surface 9. The support part 9 ensures that the combination 1, 2 is placed in a stable manner. In a preferred embodiment the support part 9 is in the form of a number of edges fastened to or integrated with the walls of the impenetrable part 7, preferably the edges are evenly distributed along the internal surface of the impenetrable part 7 so as to you offer maximum support for the infusion set. Also in a preferred embodiment the periphery of a spiral release layer 6a protecting the adhesive surface 6 is attached to the impenetrable part 7 or a part integrated with the impenetrable part 7. The spiral release layer 6a could be attached to the part impenetrable 7 when gluing, welding or mechanically. In this packaging mode the needle / cannula of the combination 1, 2 is placed in a circular central part 7a with walls that remain vertical of the internal surface of the impenetrable part 7. The central piece 5 is pressed downwards in the part corresponding circular center 7a and the friction between the part 5 and the walls in the central part 7a keep the combination 1, 2 in the precise place. In another means of the not shown embodiment 7a comprises flat springs fastened to the periphery of the impenetrable part 7 and which are pushed down onto portions of the infusion part 2 and / or parts of the needle hub 1. The flat springs may during the production will be pushed down on the part of the infusion device 2 and fastened to the periphery which will keep the combination 1, 2 in the right place. In Fig. 3 the removable part 8 is made of a paper material such as medical grade paper of full release or Tyvek coated with heat seal, and the paper material is attached to the upper edge of the impenetrable part 7. Before to apply the device the user pulls the removable part 8 making the combination accessible. The connection in the shape of a tube 4 can be wrapped around the combination 1, 2 (not shown in the figures) which makes it possible to pull the tube 4 without the tube becoming entangled. Fig. 4 shows another embodiment of the packaging where the removable part 8 is in the form of a relatively hard lid. Before applying the device the user will have to pull the removable part 8 making the combination accessible. Fig. 5 shows a modality comprising a handle for manual insertion. The handle is formed by integrating the needle hub 1 with the removable part 8, either by creating the two parts as one or by connecting the two parts in a stable manner. Fig. 6 shows an embodiment of the invention where the central piece 5 is replaced with a material 10 placed inside the circular central part 7a. In another embodiment not shown the lower part of the impenetrable part 7 is filled with this material 10, which for example can be silicone, at a height exceeding the length of the needle, in this embodiment the filling material 10 constitutes the part 9. According to this solution, the combination 1, 2 is maintained in the precise place by friction between the needle and the filling material 10. FIG. 7 shows an embodiment of the invention where a release layer 6a that covers the adhesive 6 is removed during the release of the combination 1, 2 of the packing. The release layer 6a is formed as a spiral band where one end-in this mode the end closest to the periphery-is connected to the support part 9, and the rest of the release layer 6a is releasably attached to the adhesive surface 6. Figs. 8a thr 8f illustrate one embodiment of the invention and how this mode operates during use. In] to Eig. The needle hub pack 1 and the infusion part 2 are placed within a packing according to the invention under sterile conditions, and the impenetrable part 7 protects the contact surroundings with the insertion needle 3. The removable part 8 is released from the distal edge formed by the impenetrable part 7 but is not completely removed. In fig. 8b the removable part 8 has been completely removed and the tube 4 which is connected to the infusion part 2 has been removed from the packing. In fig. 8c an inserter 11 with a handle 13 has been fastened to the needle hub 1 by pushing the inserter 11 towards the needle hub 1 through the opening that was revealed when the removable part 8 was removed. The splitter 11 comprises internal routes corresponding to the means 14 of the needle hub 1, and when the inserter 11 is pushed towards the needle hub 1 in the right angle, the needle hub 1 will be pressed in the paths of the inserter 11 causing to the needle hub 1 and the inserter 11 to be clamped together. In fig. 8d the tube 4 of the infusion device has been connected to a medical device 12 which in this embodiment has the form of an insulin pump. In fig. 8e the inserter 11 has been prepared for the insertion of the infusion set by pulling the handle 13. The act of pulling the handle could also be referred to as "squeezing" or "loading" the inserter since an internal spring in the inserter is biased through this action. In preparing the inserter 11 the needle hub 1 and the infusion part 2 are released from the packing and placed inside the inserter 11. In FIG. 8f the infusion set connected to the inserter 11 rises from the packing and is now ready to insert the infusion set. By inserting the infusion set the user places the proximal end of the inserter 11 against the skin and then the user activates the inserter 11 and causes the insertion needle 3 to penetrate the user's skin. After insertion the inserter 11 is removed, and if the needle hub 1 to which the insertion needle 3 is fastened, the inserter is suitably secured, the insertion needle 3 will be removed together with the inserter leaving only the infusion part 2 on the user's skin. Fig. 9 shows a packaging mode 7, 8 in conjunction with an inserter 11 just before the inserter 11 is attached to the needle hub 1. In this mode the retaining means 7 is pressed very firmly around the corresponding medium centerpiece -5. In order to release the strong grip of the central part 5 the internal shape of the packaging is constructed in such a way that the pressure of the inserter 11 downwards of the needle hub 1 carries the forces of the impenetrable part 7 of the packing outwards. Fig. 10 shows the appearance of the impenetrable part 7 of the packaging after the inserter 11 has been pushed down onto the needle hub 1. The diameter of the vertical walls constituting the retaining means 7a have been extended and a The result of this is that the force necessary to pull the center piece 5 out of the holding means 7 has been reduced. Fig. 11 shows a packaging mode with means for easy opening. The impenetrable part 7 is provided with an upper tongue and the removable part 8 which is preferably made of paper, has been welded to the entire surface of the tongue. A fracture line 15 isolates a corner on a piece of the upper tongue of the impenetrable part 7 and when the user opens the packaging the corner / piece is broken off of the upper tongue and the removable part that is not provided with a fractured line It will be easily removed by pulling the broken piece that is still welded to the part of the removable part 8 that covers the piece. Figs. 12-14 show an additional mode of packaging from impenetrable the exterior at three different angles. The impenetrable part 7 has an upper end which is provided with the removable part 8 and a lower end positioned opposite the upper end. Fig. 12 shows the packing from above, meaning from the upper end of the impenetrable part 7 of the packaging, where fig. 13 and 14 show two different side views of the packaging. This type of packaging according to fig. 12-14 show the impenetrable part 7 that is formed with 3 legs 7d protruding from the lower surface of the impenetrable part (7) and a substantially centered protrusion 7c within which a separate central part 7b is placed. Fig. 15 shows a packaging mode where the needle / cannula of combination 1, 2 are placed in the central part 7b. In this embodiment the central part 7b is circular and is formed as a separate part. The central part 7b is placed right from the inner surface of the impenetrable part 7 in a correspondingly formed protuberance 7c in the impenetrable part 7 of the packing. The separated central part 7b is provided along with a through groove 14, which makes the central part 7b, elastic, ie it is possible to vary the dimension of the central part 7b. The central part 7b is placed in the correspondingly shaped protrusion 7c which engages with the central part 5 of the impenetrable part 7. Since the central part 5 engages with the corresponding circular central part 7b, the central part 7b expands and the central part 7b shows on the protrusion 7c. The friction between the central piece 5 and the separate circular piece 7b placed in the correspondingly formed protuberance 7c in the impenetrable part 7 keeps the combination 1, 2 in the precise place. In addition, the friction occurring between the central part 7b and the protrusion 7c keeps the central part 7b inside the protrusion 7b of the packing, this friction being larger than the friction between the central part 7b and the combination 1, 2. In the preparation of the infusion set for the insertion of the removable part 8 is removed from the impenetrable part 7 and the combined needle hub 1 and the infusion part 2 are released from the packing either manually or by means of an inserter 11. In order to loosen the strong grip of the central piece 5, the shape of the separated central part 7b is constructed in such a way that the pressure of the inserter 11 downwards towards the needle hub 1 brings the central part 7b to expand outwards towards the protrusion 7c in the packaging, which is possible because the groove makes the central part 7b elastic. Figs. 17-19 shows a circular embodiment of the central part 7b with a through slot along the length 14. The circular central part 7b in this embodiment is provided with a circular part 16 having a diameter smaller than the diameter of the circular central part 7b by way of a shoulder portion 15 that secures and maintains the center piece 5 in the precise place. Fig. 20 shows an embodiment of the invention where a release layer 6a covering the adhesive 6 is removed during the release of the packaging combination 1, 2. The release layer 6a in this embodiment is divided into two sections where each section forms a strip such as a spiral band, thereby forming a release layer of two coils 6a. The peripheral end 17 of each strip of the release layer 6a closest to the periphery, only one shown in the figure, are connected to the impenetrable part 7 or to a part integrated with the impenetrable part 7, and the rest of the layer 6a release, is releasably secured to the adhesive surface 6. Like the single spiral release layer mentioned in the above 6a, this two spiral release layer 6a could also be connected or fastened to the impenetrable part when gluing, welding or mechanically . In this embodiment, when the inserter 11 is pressed, it is not shown in FIG. 20, downwards for the release of the combination 1, 2 of the packaging, the peripheral end 17 of each strip of the release layer 6a in the form of a small strip is pressed down towards the impenetrable part 7 of the inner packing and is glued, the glue that is placed in points corresponding to the small strips 17 inside the packaging on the impenetrable part 7. When releasing the needle hub 1 and the infusion part 2 of the packaging the release layer is then Automatically detaches from the adhesive layer. Fig. 21a shows an embodiment of the release layer 6a covering the adhesive layer, wherein the release layer 6a is a single piece and has two peripheral ends extending 17 in the form of protruding small strips proposed for fastening to the impenetrable part 7 or to a part integrated with the impenetrable part. Fig. 21 b shows another embodiment of the release layer 6a where the release layer is divided into two sections 6b and 6c, each section forming a strip such as a spiral band, in this way forming a release layer of two spirals 6a. In this embodiment each peripheral end 17 extending from each strip of the release layer 6a is also in the form of protruding small strips 17 designed to hold the impenetrable part 7 or a part integrated with the impenetrable part 7. This mode is a more suitable form of the release layer than the shape shown in FIG. 21a since the strips define a more precise length for the release of the release layer. Furthermore, by means of a single pull, the release layer can be removed from the adhesive layer in two reduced strips and only little force is required to remove it.

Claims

CLAIMS 1. Packaging for an infusion set comprising an infusion part and a needle hub where the needle hub is combined with an insertion needle, the packing comprising a support part for containing the infusion part and the cube needle, an impenetrable part that protects the surroundings of the insertion needle and a removable part that is to be removed by the user before applying the infusion part, characterized in that the internal part of the impenetrable part comprises retention means for releasably retain at least a part of the infusion set. 2. The packaging according to claim 1, characterized in that the retaining means is an integrated part of the impenetrable part. 3. The packaging according to claim 1, characterized in that the retaining means is a separate part. 4. The packaging according to claim 3, characterized in that the separated part is kept in the impenetrable part when the infusion set is released from the packing. 5. The packaging according to any of claims 1-4, characterized in that the proximal side of the infusion set is provided with an adhesive. 6. The packaging according to claim 5, characterized in that the adhesive is covered with a release layer. I. The packaging according to claim 6, characterized in that the release layer covering the adhesive is partially attached to the impenetrable part or is attached to a part that is connected to the impenetrable part. The packaging according to claim 7, characterized in that the release layer is in the form of a band and that one end of the band is attached to the impenetrable part or is attached to a part that is connected to the impenetrable part . The packaging according to claim 7, characterized in that the release layer has the shape of at least two bands where one end of each band is fastened to the impenetrable part or is attached to a part that is connected to the impenetrable part. 10. The packing according to claim 1-9, characterized in that the impenetrable part is made of a hard material. II. The packaging according to claim 10, characterized in that the impenetrable part is made of polypropylene (PP), polyethylene (PE HD) or PVC. 12. The packing according to claim 1-11, characterized in that the needle hub is provided with means for retaining a device. 13. The packaging according to claim 1-11, characterized in that the needle hub is provided with means for retaining a sertator. 14. The packing according to claim 1-11, characterized in that the needle hub is provided with means which means can retain an inserter when the inserter is pushed towards the needle hub on the distal side. 15. The packaging according to claim 1-14, characterized in that the infusion set is retained releasably by retaining means formed as an integrated part of the impenetrable part of the packaging. 16. The packaging according to claim 15, characterized in that the infusion part is provided with corresponding means that are releasable connected to the retaining means. The packaging according to claim 15, characterized in that the retaining means is formed as vertical walls of the impenetrable part at an angle between -45 ° and 45 ° where 0 ° is orthogonal to the near surface of the impenetrable part . 18. The packaging according to claim 17, characterized in that the corresponding means is formed as a cylinder or a truncated cone integrated with the infusion part. 19. The packaging according to claim 18, characterized in that the corresponding means comprises a cylinder or a truncated cone formed by a slit in the infusion part making it possible for the proximal end of the medium to be aligned to the proximal surface of the infusion part. 20. The packaging according to claim 15, characterized in that the retaining means is formed of a relatively soft material the material that can be penetrated by the insertion needle and the soft material that connects non-releasable to the impenetrable part of the packaging 21. The packing according to claim 1-17, characterized in that a supporting part parallel to the proximal surface of the infusion set is attached to the impenetrable part or formed as an integrated part of the impenetrable part. 22. The packing according to claim 1-5 or 21, characterized in that the retaining means comprises an opening of the needle and a supporting part parallel to the proximal surface of the infusion set. 23. The packaging according to claim 22, characterized in that the corresponding means comprises a cylinder or a truncated cone projecting from the proximal surface of the infusion part. 24. Method for preparing the application of an infusion set comprising an infusion part and a needle hub where the needle hub is combined with an insertion needle, the method characterized in that it comprises the following steps: - removing the removable part of packing, attach a device to the needle hub, remove the infusion set from the impenetrable part of the packing when pulling the device, and remove the release layer covering the adhesive if a release layer is present, place the proximal end of the infusion set that aims against the user's skin. 25. The method of compliance with the claim 24, characterized in removing the removable part of the packing, attaching an inserter to the needle hub, - removing the infusion set from the impenetrable part of the packing when pulling the inserter, and removing the release layer that covers the adhesive if a layer of release is present, - place the near end of the infusion set that points against the user's skin, activate the inserter. 26. Method for preparing the application of an infusion set comprising an infusion part and a needle hub where the needle hub is combined with an insertion needle, the method characterized in that it comprises the following steps: removing the removable part of the needle. packing, - attaching a device to the needle hub, removing the infusion set from the impenetrable part of the packing and removing the release layer covering the adhesive when pulling the device, - placing the proximal end of the infusion set pointing against the User skin 27. The method according to claim 24, 25 or 26, characterized in that - the handling device or inserter is tightened before removing the infusion set from the impenetrable part of the packing when pulling the device. The method according to claim 24, 25 or 26, characterized in that - the inserter handling device is tightened after removing the infusion set from the impenetrable part of the packing when pulling the device.